Menarini Group Announces Positive Topline Data From Pivotal Phase 3 BROADWAY & TANDEM Clinical Trials Evaluating Obicetrapib and the Fixed-Dose Combination Obicetrapib With Ezetimibe 10 Mg
Menarini Group Announces Positive Topline Data From Pivotal Phase 3 BROADWAY & TANDEM Clinical Trials Evaluating Obicetrapib and the Fixed-Dose Combination Obicetrapib With Ezetimibe 10 Mg
– Both pivotal studies achieved primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies with high statistical significance (p<0.0001)
– 两项主要研究在最大耐受的脂质修饰治疗基础上,均实现了LDL-C的LS均值减少的主要终点,其统计学意义高(p
– Approximately 50% of patients in BROADWAY (Obicetrapib monotherapy) and over 70% of patients in TANDEM (Fixed Dose Combination Obicetrapib with Ezetimibe) achieved LDL-C target below 55 mg/dL
– BROADWAY(Obicetrapib单药治疗)约50%的患者和TANDEm(Obicetrapib与Ezetimibe的固定剂量组合)超过70%的患者达到了LDL-C目标低于55 mg/dL
– In BROADWAY a 21% reduction in major adverse cardiovascular events favoring Obicetrapib was observed at one year
– 在BROADWAY中,观察到Obicetrapib在一年内对主要不良心血管事件的减少率为21%
-- In both studies, Obicetrapib monotherapy and the fixed dose combination with Ezetimibe were shown to be well tolerated
-- 在两项研究中,Obicetrapib单药治疗和与Ezetimibe的固定剂量组合均表现良好耐受
FLORENCE, Italy, Dec. 16, 2024 /PRNewswire/ -- Menarini Group today announces positive topline data from the Phase 3 BROADWAY (NCT05142722) and the Phase 3 TANDEM (NCT06005597) clinical trials sponsored by NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well tolerated.
FLORENCE,意大利,2024年12月16日 /PRNewswire/ -- Menarini集团今日宣布来自第三阶段BROADWAY(NCT05142722)和第三阶段TANDEm(NCT06005597)临床试验的积极顶线数据,此临床试验由NewAmsterdam制药公司N.V.(纳斯达克:NAMS或“NewAmsterdam”或“公司”)赞助,该公司是一家处于后期阶段的临床生物制药公司,开发口服非他汀类药物,针对心血管疾病(“CVD”)高风险患者,其低密度脂蛋白胆固醇(“LDL-C”)升高,现有治疗手段效果不佳或耐受性差。
The Phase 3 BROADWAY clinical trial (NCT05142722) was designed to evaluate 10 mg Obicetrapib in adult patients with heterozygous familial hypercholesterolemia ("HeFH") and/or established atherosclerotic cardiovascular disease ("ASCVD"), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
第三阶段BROADWAY临床试验(NCT05142722)旨在评估10毫克Obicetrapib对伴有显性家族性高胆固醇血症(“HeFH”)和/或确诊动脉粥样硬化心血管疾病(“ASCVD”)的成人患者的效果,这些患者的LDL-C在最大耐受的降脂治疗下仍未得到充分控制。
The phase 3 TANDEM clinical trial (NCT06005597) was designed to evaluate 10 mg Obicetrapib and 10 mg Ezetimibe fixed-dose combination in adult patients with HeFH and/or ASCVD or multiple ASCVD risk factors, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
第三阶段TANDEm临床试验(NCT06005597)旨在评估10毫克Obicetrapib与10毫克Ezetimibe固定剂量组合对伴有HeFH和/或ASCVD或多种ASCVD风险因素的成人患者的效果,这些患者的LDL-C在最大耐受的降脂治疗下仍未得到充分控制。
The primary endpoint in BROADWAY was the least-squares mean of the percent change in LDL-C from baseline to day 84 for Obicetrapib 10 mg compared to placebo. The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001).
BROADWAY中的主要终点是Obicetrapib 10毫克与安慰剂相比,从基线到第84天LDL-C的百分比变化的最小二乘均值。该主要终点以统计学意义实现,LDL-C减少了33%(p
LDL-C percentage change at Day 84: | |||
Placebo (n=844) |
Obicetrapib 10 mg (n=1686) |
Difference |
|
Mean |
-2 % |
-35 % |
-33 % |
Median |
-4 % |
-40 % |
-36 % |
LS mean |
+3 % |
-30 % |
-33 % |
在第84天LDL-C百分比变化: | |||
安慰剂 (n=844) |
Obicetrapib 10毫克 (n=1686) |
差异 |
|
平均值 |
-2 % |
-35 % |
-33 % |
中位数 |
-4 % |
-40 % |
-36 % |
LS意味着 |
+3 % |
-30 % |
-33 % |
The observed changes in other biomarkers, including increase of high-density lipoprotein cholesterol ("HDL-C") and reduction of non-HDL-C, lipoprotein(a) ("Lp(a)"), apolipoprotein B ("ApoB"), and Apolipoprotein A1 (ApoA1) were positive and consistent with data reported from prior clinical trials.
观察到的其他生物标志物的变化,包括高密度脂蛋白胆固醇("HDL-C")的增加和非高密度脂蛋白胆固醇、脂蛋白(a)("Lp(a)")、载脂蛋白B("ApoB")和载脂蛋白A1(ApoA1)的减少,这些都是积极的,并且与之前临床试验报告的数据一致。
As part of the safety analysis, key adverse events ("AE") of special interests were monitored. Among these AEs, glycemic control and renal function favoured Obicetrapib.
作为安全性分析的一部分,监测了特定关键不良事件("AE")。在这些不良事件中,血糖控制和肾功能对Obicetrapib有利。
In addition, the BROADWAY trial adjudicated MACE, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization showing a 21% reduction in the first 4-point MACE favoring Obicetrapib.
此外,BROADWAY试验审核了主要不良心血管事件(MACE),包括死亡、非致命性心肌梗死、非致命性中风和冠状动脉再血管化,结果显示前四项主要不良心血管事件减少了21%,支持Obicetrapib。
Major adverse cardiovascular events table: | ||||
Placebo (n = 844) |
Obicetrapib 10 mg (n= 1686) |
Hazard Ratio |
95% CI |
|
All-cause mortality – no. (%) |
12 (1.4) |
19 (1.1) |
0.83 |
(0.40-1.71) |
Coronary heart death – no. (%) |
5 (0.6) |
8 (0.5) |
0.80 |
(0.26-2.44) |
First 4-point MACE – no. (%) |
44 (5.2) |
70 (4.2) |
0.79 |
(0.54-1.15) |
4-point MACE: CHD death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization. MACE was not a primary or secondary endpoint of the BROADWAY trial. |
重大不良心血管事件表: | ||||
安慰剂 (n = 844) |
Obicetrapib 10毫克 (n= 1686) |
危险比 |
95%置信区间 |
|
全因死亡 – 例数 (%) |
12 (1.4) |
19 (1.1) |
0.83 |
(0.40-1.71) |
冠心病死亡 – 否. (%) |
5 (0.6) |
8 (0.5) |
0.80 |
(0.26-2.44) |
第一次4点MACE – 否. (%) |
44 (5.2) |
70 (4.2) |
0.79 |
(0.54-1.15) |
4点主要不良心血管事件:冠心病死亡、非致命性心肌梗死、非致命性中风、冠状动脉重建。主要不良心血管事件不是BROADWAY试验的主要或次要终点。 |
Overall, Obicetrapib was also observed to be well tolerated, with safety data, including blood pressure, comparable to placebo. The treatment discontinuation rate for the Obicetrapib arm was 11.1% versus 12.4% for placebo. The incidence of treatment-emergent adverse events ("TEAEs"), study-drug related TEAEs, and treatment-emergent serious adverse events ("TESAEs") are summarized in the table below.
总体而言,Obicetrapib的耐受性良好,安全性数据(包括血压)与安慰剂相当。Obicetrapib组的治疗中断率为11.1%,而安慰剂组为12.4%。治疗引起的不良事件("TEAEs")、与研究药物相关的TEAEs以及治疗引起的严重不良事件("TESAEs")在下表中总结。
Placebo (n=843) |
Obicetrapib 10 mg (n=1,685) |
|
Any TEAEs – no. (%) |
513 (60.9) |
1007 (59.8) |
Any trial drug related TEAEs – no (%) |
39 (4.6) |
76 (4.5) |
Any TEAEs leading to discontinuation of trial drug – no. (% |
43 (5.1) |
68 (4.0) |
Any TESAEs – no. (%) |
117 (13.9) |
211 (12.5) |
Placebo (n=843) |
Obicetrapib 10 mg (n=1,685) |
|
任何TEAE – 否. (%) |
513 (60.9) |
1007 (59.8) |
任何试验药物相关的不良事件 – 无 (%) |
39 (4.6) |
76 (4.5) |
任何导致停止试验药物的TEAEs - 否. (%) |
43 (5.1) |
68 (4.0) |
任何TESAE – 无(%) |
117 (13.9) |
211 (12.5) |
The co-primary endpoints in TANDEM were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and Obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other biomarkers, including Lp(a), non-HDL-c and APO B.
TANDEm中的共同主要终点是固定剂量组合与每个单药臂在84天后的LDL-C基线变化百分比,以及Obicetrapib 10毫克与安慰剂在84天后的比较。其他终点包括其他生物标志物的基线变化百分比,包括Lp(a)、非HDL-c和APO b。
The TANDEM trial met all co-primary endpoints, including the fixed dose combination Obicetrapib with Ezetimibe achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84.
TANDEm试验满足所有共同主要终点,包括固定剂量组合Obicetrapib与Ezetimibe在第84天相比安慰剂实现了48.6%的LS均值减少(p
LDL-C percentage change at Day 84
第84天LDL-C的百分比变化
Ezetimibe (n=101) |
Obicetrapib (n=102) |
Obicetrapib and Ezetimibe FDC (n=102) |
|
Day 84 – from placebo |
|||
Mean % |
-23.3 |
-35.5 |
-52.2 |
Median % |
-22.6 |
-37.2 |
-54.0 |
LS mean % |
-20.7 |
-31.9 |
-48.6 |
Comparison to pbo |
- |
(p<0.0001) |
(p<0.0001) |
Comparison to eze 10 mg |
- |
- |
(p<0.0001) |
Comparison to obi 10 mg |
- |
- |
(p=0.0007) |
依泽替米 (n=101) |
奥比切拉比 (n=102) |
Obicetrapib和 依泽替米和 (n=102) |
|
第84天 – 来自安慰剂 |
|||
平均百分比 |
-23.3 |
-35.5 |
-52.2 |
中位数% |
-22.6 |
-37.2 |
-54.0 |
LS均值% |
-20.7 |
-31.9 |
-48.6 |
与pbo的比较 |
- |
(p |
(p |
与eze 10毫克的比较 |
- |
- |
(p |
与 obi 10 毫克的比较 |
- |
- |
(p=0.0007) |
In the trial, the fixed-dose combination of Obicetrapib and Ezetimibe was observed to be well tolerated, with safety data comparable to placebo. The below table summarizes study drug-related treatment emergent adverse events ("TEAEs") and study drug-related treatment emergent serious adverse events ("TESAEs").
在试验中,Obicetrapib与Ezetimibe的固定剂量组合被观察到耐受性良好,安全性数据与安慰剂相当。以下表格总结了与研究药物相关的治疗出现的不良事件("TEAEs")和与研究药物相关的治疗出现的严重不良事件("TESAEs")。
Placebo (n=102) |
Ezetimibe (n=101) |
Obicetrapib (n=102) |
Obicetrapib / Ezetimibe FDC (n=102) |
|
Any study drug-related TEAEs |
4 (3.9 %) |
3 (3.0 %) |
7 (6.9 %) |
3 (2.9 %) |
Any study drug-related TEAEs leading to discontinuation of study drug |
2 (2.0 %) |
1 (1.0 %) |
6 (5.9 %) |
1 (1.0 %) |
Any study drug related TESAEs |
0 (0.0 %) |
0 (0.0 %) |
0 (0.0 %) |
0 (0.0 %) |
安慰剂 (n=102) |
Ezetimibe (n=101) |
奥比切拉比 (n=102) |
Obicetrapib / 依泽替米 FDC (n=102) |
|
任何与药物相关的TEAEs |
4 (3.9 %) |
3 (3.0 %) |
7 (6.9 %) |
3 (2.9 %) |
任何与药物相关的TEAE导致停止使用药物的研究 |
2 (2.0 %) |
1 (1.0 %) |
6 (5.9 %) |
1 (1.0 %) |
任何与研究药物相关的重大不良事件 |
0 (0.0 %) |
0 (0.0 %) |
0 (0.0 %) |
0 (0.0 %) |
"Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives each year. Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets, many patients failing to achieve guidelines recommended LDL.C target goals. Patients and their doctors need additional options. We are very pleased that BROADWAY and TANDEM data and previously announced BROOKLYN data confirmed the ability of Obicetrapib as a monotherapy or in a fixed dose combination with ezetimibe to significantly reduce LDL-C and help patients achieve recommended target goals. This represents a key milestone in our commitment to offer patients suffering from cardiovascular diseases in Europe, a potential first in class, low dose, once daily oral treatment in the fight against cardiovascular diseases, a mission of over 30 years for our company" said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
"Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 1790万 lives each year. Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets, many patients failing to achieve guidelines recommended LDL.C target goals. Patients and their doctors need additional options. We are very pleased that BROADWAY and TANDEm data and previously announced BROOKLYN data confirmed the ability of Obicetrapib as a monotherapy or in a fixed dose combination with ezetimibe to significantly reduce LDL-C and help patients achieve recommended target goals. This represents a key milestone in our commitment to offer patients suffering from cardiovascular diseases in Europe, a potential first in class, low dose, once daily oral treatment in the fight against cardiovascular diseases, a mission of over 30 years for our company" said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
Design of the Pivotal Phase 3 BROADWAY Clinical Trial
关键第三阶段BROADWAY临床试验设计
The 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter study evaluated the efficacy and safety of 10 mg Obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled. The study was conducted at sites in North America, Europe, Asia and Australia. A total of 2,530 patients were randomized 2:1 to receive 10 mg Obicetrapib or placebo dosed as a once-daily oral treatment, with or without food for 52 weeks. The mean baseline LDL-C for enrolled patients in the Obicetrapib arm was approximately 100 mg/dL despite high intensity statin use reported by nearly 70% of patients during screening. Females comprised approximately 34% of the study population and the median age of participants at baseline was 65 years.
The 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter study evaluated the efficacy and safety of 10 mg Obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled. The study was conducted at sites in North America, Europe, Asia and Australia. A total of 2,530 patients were randomized 2:1 to receive 10 mg Obicetrapib or placebo dosed as a once-daily oral treatment, with or without food for 52 weeks. The mean baseline LDL-C for enrolled patients in the Obicetrapib arm was approximately 100 mg/dL despite high intensity statin use reported by nearly 70% of patients during screening. Females comprised approximately 34% of the study population and the median age of participants at baseline was 65 years.
The primary endpoint was percent change from baseline in LDL-C of Obicetrapib 10 mg compared to placebo after 84 days which showed a reduction of 33% with imputation. Secondary endpoints also included percent changes from baseline of Obicetrapib 10 mg compared to placebo in ApoB, Lp(a), ApoA1, HDL-C, non-HDL-C, total cholesterol, and triglycerides at day 84, and on LDL-C levels at days 180 and 365 (-34% and -24%, respectively with p<0.0001). Other outcome measures include time from randomization until the first confirmed occurrence of MACE in the Obicetrapib arm compared to placebo. The trial also evaluated the safety and tolerability profile of Obicetrapib.
The primary endpoint was percent change from baseline in LDL-C of Obicetrapib 10 mg compared to placebo after 84 days which showed a reduction of 33% with imputation. Secondary endpoints also included percent changes from baseline of Obicetrapib 10 mg compared to placebo in Apob, Lp(a), ApoA1, HDL-C, non-HDL-C, total cholesterol, and triglycerides at day 84, and on LDL-C levels at days 180 and 365 (-34% and -24%, respectively with p
Design of the Pivotal Phase 3 TANDEM Clinical Trial
关键的第3期TANDEm临床试验设计
The pivotal, Phase 3, randomized, double-blind, four-arm, placebo-controlled multicenter study evaluated the effect of 10 mg Obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and Obicetrapib 10 mg monotherapy and to placebo. The study was conducted at sites across the United States, and a total of 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who had a baseline LDL-C of at least 70 mg/dL, were randomized 1:1:1:1 to receive 10 mg Obicetrapib and 10 mg ezetimibe fixed-dose combination, 10 mg Obicetrapib, 10 mg ezetimibe or placebo for an 84-day treatment period. The mean baseline LDL-C for enrolled patients in the obicetrapib-ezetimibe arm was 97 mg/dL despite high intensity statin use reported by approximately 74% of patients during screening. In addition to measuring the co-primary endpoints and secondary endpoints, the trial also evaluated the safety and tolerability profile of Obicetrapib.
这项关键的第3期、随机、双盲、四组、安慰剂对照的多中心研究评估了10毫克Obicetrapib和10毫克依泽替米贝作为固定剂量组合对LDL-C水平的影响,比较了10毫克依泽替米贝、10毫克Obicetrapib单药治疗和安慰剂。该研究在美国各地的多个中心进行,共招募407名患有家族性高胆固醇血症(HeFH)和/或动脉粥样硬化性心血管疾病(ASCVD)或ASCVD风险等同症的患者,他们的基线LDL-C水平至少为70 mg/dL,随机分为1:1:1:1接受10毫克Obicetrapib和10毫克依泽替米贝固定剂量组合、10毫克Obicetrapib、10毫克依泽替米贝或安慰剂,治疗周期为84天。尽管约74%的患者在筛查时报告使用了高强度的他汀类药物,但在Obicetrapib-依泽替米贝组登记患者的平均基线LDL-C为97 mg/dL。除了测量共同主要终点和次要终点外,该试验还评估了Obicetrapib的安全性和耐受性。
Obicetrapib's Global Pivotal Phase 3 Program
Obicetrapib的全球关键第3期计划
Obicetrapib global, pivotal Phase 3 clinical development program consists of four studies in over 12,250 patients, three for obicetrapib monotherapy and one for the fixed-dose combination ("FDC") with ezetimibe:
Obicetrapib全球关键第3期临床开发计划由四项研究组成,涉及超过12,250名患者,其中三项为Obicetrapib单药治疗,一项为与依泽替米贝的固定剂量组合("FDC"):
- BROOKLYN evaluated Obicetrapib in patients with HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05425745). Study enrollment of over 350 patients was completed in April 2023. Topline data reported in the third quarter of 2024.
- BROADWAY evaluated Obicetrapib in adult patients with established ASCVD and/or HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05142722). Study enrollment of over 2,500 patients was completed in July 2023. Topline data reported in the fourth quarter of 2024.
- TANDEM evaluated Obicetrapib as part of a FDC tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy (NCT06005597). Study enrollment of over 400 patients was completed in July 2024. Topline data reported in November 2024
- PREVAIL is a cardiovascular outcomes trial ("CVOT") evaluating Obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05202509). Study enrollment of over 9,500 patients was completed in April 2024.
- BROOKLYN研究评估了在最大耐受的降脂治疗下,LDL-C未能得到充分控制的HeFH患者中的Obicetrapib(NCT05425745)。研究招募超过350名患者,并于2023年4月完成。预计在2024年第三季度报告顶层数据。
- BROADWAY研究评估了在最大耐受的降脂治疗下,LDL-C未能得到充分控制的已确诊ASCVD和/或HeFH的成年患者中的Obicetrapib(NCT05142722)。研究招募超过2,500名患者,并于2023年7月完成。预计在2024年第四季度报告顶层数据。
- TANDEm研究评估了Obicetrapib作为与依泽替米贝的FDC片剂的组成部分,在已确诊的ASCVD或多重ASCVD风险因素和/或HeFH患者中,尽管接受了最大耐受的降脂治疗,但LDL-C未能得到充分控制(NCT06005597)。研究招募超过400名患者,并于2024年7月完成。预计在2024年11月报告顶层数据。
- PREVAIL是一项心血管结果试验("CVOT"),评估Obicetrapib用于有动脉粥样硬化性心血管疾病(ASCVD)病史的患者,他们的LDL-C未能得到有效控制,尽管接受了最大耐受的降脂治疗(NCT05202509)。该研究的入组超过9,500名患者已于2024年4月完成。
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor under development to overcome the limitations of current LDL-lowering treatments. In each of the Phase 2 trials, ROSE2, TULIP, ROSE, as well as the Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating Obicetrapib as monotherapy or combination therapy, it was observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo.
The Phase 3 study cardiovascular outcomes trial PREVAIL commenced in March 2022 and is designed to assess the potential of Obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. The enrollment of PREVAIL was completed in April 2024 and randomized over 9,500 patients.
关于Obicetrapib
Obicetrapib是一种新型的口服低剂量CETP抑制剂,正在开发中,以克服现有LDL降脂治疗的局限性。在每个第2期试验中,包括ROSE2、TULIP、ROSE,以及第3期BROOKLYN、BROADWAY和TANDEm试验,评估Obicetrapib作为单药或联合治疗,观察到LDL显著降低,且其副作用特征与安慰剂相似。
第3期心血管结果试验PREVAIL于2022年3月启动,旨在评估Obicetrapib减少重大不良心血管事件发生的潜力,包括心血管死亡、非致命性心肌梗死、非致命性中风和非选定性冠状动脉再血管化。PREVAIL的入组于2024年4月完成,并随机超过9,500名患者。
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas of high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit .
关于Menarini集团
Menarini集团是一家领先的国际药品和诊断公司,年营业额达到47亿,员工超过17,000人。Menarini专注于高未满足需求的治疗领域,提供心脏病学、肿瘤学、肺病学、胃肠病学、传染病、糖尿病、炎症和镇痛等产品。Menarini拥有18个生产基地和9个研发中心,其产品在全球140个国家销售。欲了解更多信息,请访问。
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating Obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
关于新阿姆斯特丹
NewAmsterdam Pharma(纳斯达克:NAMS)是一家晚期生物制药公司,其使命是改善患有代谢疾病的患者护理,目前批准的疗法尚未充分或耐受良好。我们致力于填补安全、耐受良好且方便的LDL降脂治疗的重大未满足需求。在多项第3期研究中,NewAmsterdam正在研究Obicetrapib,一种口服低剂量每日一次的CETP抑制剂,作为单药或与依泽替米贝的固定剂量组合,作为LDL-C降脂治疗,作为他汀类药物治疗的辅助治疗,适用于LDL-C升高、已有CVD风险且现有疗法效果不足或耐受性差的患者。
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SOURCE Menarini Industrie Farmaceutiche Riunite
来源:梅纳里尼制药工业联合公司